BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 1081483 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-08119
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 11, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 26 MONTHS, DUE TO UNK REASONS. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention